The present invention is directed to a novel device and method for providing a disposable endotracheal intubation device for use in conjunction with an auxiliary passageway serving as a guide for the placement of an orogastic or other enterally directed device in a patient.
An early airway apparatus for assisting in artificial respiration of a patient comprised an arcuate, open-ended tubular member which was adapted to be inserted into the patient's trachea. The tubular member carried an external, inflatable resilient sleeve (cuff near the distal end thereof for affecting a seal with the inner wall of the trachea. Following the placement of this endotracheal tube (catheter) respiratory device (a procedure known as endotracheal intubation), it would often be necessary to additionally place within the patient an orogastric (OG) or nasogastric (NG) tube for a number of clinical functions, including, for example, suction of gastric contents, suction of aspiration secretions, suction of air from an inflated stomach, placement of contrast materials and feeding.
However, the placement of an NG tube through the patient's nasal passageway is fraught with potentially serious complications. For example, placement of an NG tube into a patient can cause pressure necrosis of the nasal vestibule, traumatize the nasal mucosa causing massive hemorrhage, puncture the cranial vault, cause toxic shock, perforate the back of the throat, and cause occlusion of facial sinus draining tracts leading to serious infections. Furthermore, passage of an NG tube into a patient many times is only possible by placing one's hand into the patient's posterior orpharynx to facilitate the further directing of the tube into the proximal esophagus.
Similarly, it is often difficult placing an OG tube in a patient due to problems navigating the OG tube past an obstructing tongue of the patient thereby warranting placement of the health practitioner's hand into the patient's posterior orpharynx to direct the tube into the proximal esophagus.
The conventional way of placing the NG and OG tubes after endotracheal intubation place the patient at iatrogenic risk of injury and the health practitioner/operator at risk of being bitten or exposed to enumerable infectious diseases from placing his or her hands into the patient's mouth.
Separate endotracheal, NG and OG tubes are known in the art, as are various devices and methods for using them in combination. A commonly used endotracheal tube utilizes a dual lumen system, where the primary lumen comprises an open-ended tubular member which, when placed into the patient, extends at its distal end into the patient's trachea, and at its opposite end, remains external to the patient. This endotracheal tube commonly employs an external, inflatable resilient sleeve or cuff near the distal end thereof for affecting a seal with the inner wall of the trachea. The sleeve is inflated via a second lumen attached proximate the endotracheal tube. Dual lumen endotracheal tubes are available under a number of brand names, including the Mallinckrodt® brand. A standard dual lumen endotracheal tube employing an inflatable cuff is shown and described in U.S. Pat. No. 3,625,793 to Sheridan. U.S. Pat. No. 4,584,998 to McGrail (owned by Mallinckrodt), discloses a multi-lumen tracheal tube wherein the standard endotracheal tube employs up to three lumens for conducting various functions associated within the patient's trachea, such as high frequency ventilation. U.S. Pat. No. 5,143,062 to Peckham discloses a standard dual lumen endotracheal tube having a third lumen for use in suctioning the patient's secretions pooled in the trachea above the tube's inflated cuff. Skoljarev—DE19533615 (Abstract) shows an endotracheal tube employing a suction catheter, the tube and catheter encased within an oropharyngeal tube protecting same from being bitten by the patient.
Numerous multi-lumen esophageal/tracheal airway devices exist that are designed to allow for blind (without use of a laryngoscope) insertion of the device into the patient. Typically, these dual lumen airway devices employ one elongated lumen having an inflation cuff similar to a standard endotracheal tube wherein the cuff is located near the distal end of the tube. The other lumen is typically shorter in length and employs an inflation cuff located on the proximal side of openings in the shorter lumen. The device is configured such that either lumen could be used for ventilation regardless of which lumen enters the trachea The non-ventilating lumen can be used to remove gastric fluids. If the longer lumen enters the trachea, its cuff seals the trachea and the longer lumen can be used for ventilation, while the opening of the shorter lumen would be proximate the pharyngeal area of the patient where a seal can be formed to direct gastric fluids into the lumen. This prior art also discloses means of marking the endotracheal tubes with, e.g., an X-ray opaque stripe to facilitate the placement and orientation of the airway and the location of the inflatable cuffs.
For example, Fortuna, US 2004/0020491 A1, describes a combination artificial airway device and esophageal obturator that includes an esophageal cuff and a supraglottic cuff that are inflated in a sequence to provide quick isolation of the esophagus relative to the tracheal air passage. The esophageal cuff is designed to enter the esophagus and to create a seal around the esophagus with the inflatable cuff. The supraglottic cuff does not enter the trachea, but instead inflates to form a seal. Fortuna further describes that if necessary, an oro-gastric tube can be passed directly to the stomach through the esophageal limb. The portion of the esophageal limb passing through the supraglottic cuff is integrated internal to the supraglottic cuff. A disadvantage of this device is that the airway created is temporary and not secure, and would not be used where medical judgment calls for the use of an endotracheal tube having a cuffed end that physically enters the trachea.
Angel, US 2004/0000314 A1, describes a multi-lumen airway assembly used in a procedure that requires instrumentation to be inserted in an air passage (i.e., larynx, trachea, bronchi or bronchioles) of a patient. The multi-lumen device of Angel is designed to pass through the trachea and into the bronchii. Angel describes an airway assembly employing a reinforced, flexible first conduit, a second conduit (e.g., suction conduit), a third conduit (e.g., ventilation conduit) and an expandable member.
U.S. Pat. No. 5,499,625 to Frass et al. discloses a twin lumen, dual balloon cuff coaxial device designed for use in emergency situations and difficult airways. It can be inserted blindly into the oropharynx and usually enters the esophagus in about 90% of times, and X-ray opaque markings on the lumen assist medical personnel in ascertaining placement and positioning of the device. It is designed to provide effective lung ventilation regardless of whether esophageal or tracheal placement is accomplished. When placed in the trachea, its ventilation function is much like a traditional endotracheal tube. When placed in the esophagus, ventilation is possible through the other coaxial lumen via the use of perforations found between two inflation cuffs.
Ranzinger—US 2003/0183234 A1, describes a dual lumen, dual balloon cuff resuscitation tube. This resuscitation tube comprises a tube wall for alternative artificial endotracheal or esophageal obturator respiration, with a first lumen and a second lumen extending substantially parallel thereto, wherein a first inflatable balloon surrounding the tube wall is disposed in the region of the end of the resuscitation tube facing the body, and a second inflatable balloon surrounding the tube wall is disposed at a separation from the first inflatable balloon, an axial opening of the first lumen is disposed directly at the end of the second balloon facing the body, and the resuscitation tube is formed with one lumen in the region of the first balloon. This permits insertion of intubation aids via the first lumen such that the resuscitation tube can be used with versatility. Similarly with Frass et al., when placed in the trachea, the resuscitation tube's ventilation function is much like a traditional endotracheal tube. When placed in the esophagus, ventilation is possible through the other lumen via the use of perforations found between two inflation cuffs.
Sniadach—US 2003/0062039 A1, describes an intubation system employing an esophageal obturator, and intubation slide, a guide wire and an endotracheal airway tube.
Alfery—U.S. Pat. No. 6,729,325, discloses a perilaryngeal oral airway and supraglottic airway which is capable of acting as an entotracheal tube guide and which seats deep in a patent's hypopharynx to prevent the soft tissue of the glottis and epiglottis from obstructing the airway.
Insler, et al.—U.S. Pat. No. 5,588,424, describes a bronchial blocker endotracheal apparatus employing two lumen. The principal lumen serves to enter and create a cuffed seal within the trachea to ventilate one or both lungs. The second tube also enters the trachea, is permitted to pass below the first lumen's cuff and serves the function of slidably receiving an endobrochial blocker (having a cuffed catheter) that can be positioned into the right or the left bronchus and the cuff inflated to occlude the selected bronchus.
U.S. Pat. Nos. 5,353,787 and 5,253,643, both to Price, disclose an standard endotracheal tube device that is demountably attachable to an oral airway device.
White, et al.—U.S. Pat. No. 4,774,945, discloses a naso-intubation system employing a speech facilitator tube and valve to permit the patient to speak while intubated.
In Scarberry—U.S. Pat. No. 4,351,330, an emergency resuscitation apparatus is provided by an endotracheal tube having a tracheal obturator and a second expandable cuff for sealing against the pharyngeal tissues to provide an alternate sealing means for respiratory fluids if the blind intubation is not successful. Scarberry—U.S. Pat. No. 4,231,365, describes a dual lumen emergency internal defibrillation apparatus.
Dryden—U.S. Pat. No. 4,256,099 and Elam U.S. Pat. No. 4,090,518 also describe a dual lumen resuscitation systems.
Frankel—EPO 0 230 790 discloses an endotracheal tube that is inserted into the patient along a tracked guide located on a flexible tube such as an esophageal tube.
Klepper—U.S. Pat. No. 6,460,540 discloses an endotracheal tube sump assembly attachable to the outside of the endotracheal tube.
Bowden et al.—U.S. Pat. No. 6,374,827 discloses a dual lumen tracheo-esophageal tube and ventilator for pneumatic cardiopulmonary resuscitation.
However, in contrast, none of the above prior art provide an improved device and method to safely facilitate the process of placing within a patient, an enteral tube after endotracheal intubation.